Open and Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia Versus General Anesthesia

NCT05837013 | Completed

• 1 other identifier: 33333333
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the most frequently applied method is laparoscopic total extraperitoneal repair (TEP). In general, this surgery is performed under general anesthesia (GA) in many centers. However, in cases where general anesthesia is inconvenient, local or other anesthesia methods are preferred. It has been stated in many studies in the literature that this surgery can be performed with methods other than general anesthesia. In a study of 480 patients, one of which was Sinha et al., it was shown that this surgical procedure was successfully performed under spinal anesthesia (SA). In a prospective randomized study by Dönmez et al., patients who underwent TEP under general anesthesia and spinal anesthesia were compared. It has been reported that TEP repair can be performed safely under SA and that SA is associated with less postoperative pain, better recovery, and better patient satisfaction than GA.2 In a retrospective study by Yıldırım et al. It has been shown that there is significantly less need for analgesics and better patient satisfaction. There are also many meta-analyses made on this subject in the literature. Compared with GA in these, SA was associated with a longer operative time, and postoperative pain and nausea and vomiting were less in SA. However, the risk of urinary retention in SA was significantly increased. It was observed that there was no significant difference in surgical complications such as seroma and wound infection. Despite all these studies, until now, there is no clear consensus on which anesthesia should be used. The aim of the study is to show the effect of both the surgical method and the anesthesia method on the patient during surgery and in the early postoperative period in inguinal hernia

Conditions

Pain, Postoperative; Postoperative Complications; Inguinal Hernia

Keywords

spinal anesthesia; inguinal Hernia; general anesthesia; laparoscopic total extraperitoneal repair

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  It will be measured using the Visual Analog Score (VAS). The patient will be asked to choose between the number 1 with the least pain and the number 10 with the most pain. The lowest score on this scale is 1, and the highest score is 10.

  Postoperative 24 hours

Secondary Outcomes (1)

• Adverse postoperative events

  Postoperative 24 hours

Study Arms (4)

General anesthesia (GA) and TEP Group

EXPERIMENTAL

General anesthesia: No premedication will be applied. In the waiting room, 10 mL/kg of Ringer's lactate solution will be infused IV in 30 minutes. In Group I, 2-2.5 mg/kg propofol and 1 μg/kg fentanyl IV will be given for induction; 0.6 mg/kg rocuronium will then be used to provide the muscle relaxation needed for intubation. After intubation, the tidal volume will be set to 6-8 mL/kg and the respiratory frequency PetCO2 32-36 mmHg in volume-controlled ventilation (VCV) mode. Anesthesia will continue to be provided with sevoflurane (1.5%-2%), oxygen-air mixture (FiO 2 = 0.4) and repeated doses of rocuronium (0.015 mg/kg). At the end of the surgery, neostigmine (2-2.5 mg) and atropine (1 mg) will be given IV to antagonize the residual neuromuscular block.

Procedure: General anesthesia (GA)

Spinal anesthesia (with nerve block) (SA) and TEP Group

ACTIVE COMPARATOR

Spinal Anesthesia and Nerve Block: No premedication will be applied. Spinal anesthesia will be administered to the patients in this group in the sitting position with a 27G Quincke needle (15 mg hyperbaric 0.5% bupivacaine) to be entered through the L2-L3 or L3-L4 interval. If hypotension develops, it will be corrected with a crystalloid infusion and ephedrine. These patients will be administered intravenous sedation with increasing doses of midazolam to provide adequate sedation. According to Hadzic, II and IH nerve block will be performed by applying 10 mL of 0.75% ropivacaine 2 cm above and 2 cm medial to the anterior superior iliac spine.

Procedure: Spinal anesthesia (with nerve block)

General anesthesia (GA) and open surgical procedure (Lichtenstein)

EXPERIMENTAL

General anesthesia: No premedication will be applied. In the waiting room, 10 mL/kg of Ringer's lactate solution will be infused IV in 30 minutes. In Group I, 2-2.5 mg/kg propofol and 1 μg/kg fentanyl IV will be given for induction; 0.6 mg/kg rocuronium will then be used to provide the muscle relaxation needed for intubation. After intubation, the tidal volume will be set to 6-8 mL/kg and the respiratory frequency PetCO2 32-36 mmHg in volume-controlled ventilation (VCV) mode. Anesthesia will continue to be provided with sevoflurane (1.5%-2%), oxygen-air mixture (FiO 2 = 0.4) and repeated doses of rocuronium (0.015 mg/kg). At the end of the surgery, neostigmine (2-2.5 mg) and atropine (1 mg) will be given IV to antagonize the residual neuromuscular block.

Procedure: General anesthesia (GA)

Spinal anesthesia (with nerve block) (SA) open surgical procedure (Lichtenstein)

ACTIVE COMPARATOR

Spinal Anesthesia and Nerve Block: No premedication will be applied. Spinal anesthesia will be administered to the patients in this group in the sitting position with a 27G Quincke needle (15 mg hyperbaric 0.5% bupivacaine) to be entered through the L2-L3 or L3-L4 interval. If hypotension develops, it will be corrected with a crystalloid infusion and ephedrine. These patients will be administered intravenous sedation with increasing doses of midazolam to provide adequate sedation. According to Hadzic, II and IH nerve block will be performed by applying 10 mL of 0.75% ropivacaine 2 cm above and 2 cm medial to the anterior superior iliac spine.

Procedure: Spinal anesthesia (with nerve block)

Interventions

Spinal anesthesia (with nerve block) PROCEDURE

Spinal Anesthesia and Nerve Block: No premedication will be applied. Spinal anesthesia will be administered to the patients in this group in the sitting position with a 27G Quincke needle (15 mg hyperbaric 0.5% bupivacaine) to be entered through the L2-L3 or L3-L4 interval. If hypotension develops, it will be corrected with a crystalloid infusion and ephedrine. These patients will be administered intravenous sedation with increasing doses of midazolam to provide adequate sedation. According to Hadzic, II and IH nerve block will be performed by applying 10 mL of 0.75% ropivacaine 2 cm above and 2 cm medial to the anterior superior iliac spine.

Spinal anesthesia (with nerve block) (SA) and TEP Group; Spinal anesthesia (with nerve block) (SA) open surgical procedure (Lichtenstein)

General anesthesia (GA) PROCEDURE

General anesthesia: No premedication will be applied. In the waiting room, 10 mL/kg of Ringer's lactate solution will be infused IV in 30 minutes. In Group I, 2-2.5 mg/kg propofol and 1 μg/kg fentanyl IV will be given for induction; 0.6 mg/kg rocuronium will then be used to provide the muscle relaxation needed for intubation. After intubation, the tidal volume will be set to 6-8 mL/kg and the respiratory frequency PetCO2 32-36 mmHg in volume-controlled ventilation (VCV) mode. Anesthesia will continue to be provided with sevoflurane (1.5%-2%), oxygen-air mixture (FiO 2 = 0.4) and repeated doses of rocuronium (0.015 mg/kg). At the end of the surgery, neostigmine (2-2.5 mg) and atropine (1 mg) will be given IV to antagonize the residual neuromuscular block.

General anesthesia (GA) and TEP Group; General anesthesia (GA) and open surgical procedure (Lichtenstein)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with inguinal hernias.
• Over 18 years old

You may not qualify if:

• Younger than 18 years
• Those who have had previous abdominal surgery,
• Incarcerated or strangulated inguinal hernias,
• Recurrent hernias,
• Coagulopathies,
• Patients with musculoskeletal deformity,
• Those with chronic pain,
• Those who use drugs that affect the central nervous system daily,
• Those with a body mass index (BMI) over 40 kg/m2,
• Patients with contraindications to the recommended anesthetic technique.

Sponsors & Collaborators

• Konya City Hospital: lead
• Van Training and Research Hospital: collaborator

Study Sites (1)

University of Health Science Van Training and Research Hospital

Van, Turkey (Türkiye)

Location

Related Publications (5)

• Sinha R, Gurwara AK, Gupta SC. Laparoscopic total extraperitoneal inguinal hernia repair under spinal anesthesia: a study of 480 patients. J Laparoendosc Adv Surg Tech A. 2008 Oct;18(5):673-7. doi: 10.1089/lap.2007.0219.

  PMID: 18803509 BACKGROUND

• Donmez T, Erdem VM, Sunamak O, Erdem DA, Avaroglu HI. Laparoscopic total extraperitoneal repair under spinal anesthesia versus general anesthesia: a randomized prospective study. Ther Clin Risk Manag. 2016 Oct 27;12:1599-1608. doi: 10.2147/TCRM.S117891. eCollection 2016.

  PMID: 27822053 BACKGROUND

• Yildirim D, Hut A, Uzman S, Kocakusak A, Demiryas S, Cakir M, Tatar C. Spinal anesthesia is safe in laparoscopic total extraperitoneal inguinal hernia repair. A retrospective clinical trial. Wideochir Inne Tech Maloinwazyjne. 2017 Dec;12(4):417-427. doi: 10.5114/wiitm.2017.72325. Epub 2017 Dec 29.

  PMID: 29362658 BACKGROUND

• Li L, Pang Y, Wang Y, Li Q, Meng X. Comparison of spinal anesthesia and general anesthesia in inguinal hernia repair in adult: a systematic review and meta-analysis. BMC Anesthesiol. 2020 Mar 10;20(1):64. doi: 10.1186/s12871-020-00980-5.

  PMID: 32156258 BACKGROUND

• Hajibandeh S, Hajibandeh S, Mobarak S, Bhattacharya P, Mobarak D, Satyadas T. Meta-Analysis of Spinal Anesthesia Versus General Anesthesia During Laparoscopic Total Extraperitoneal Repair of Inguinal Hernia. Surg Laparosc Endosc Percutan Tech. 2020 Aug;30(4):371-380. doi: 10.1097/SLE.0000000000000783.

  PMID: 32217883 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications; Hernia, Inguinal

Interventions

Anesthesia, Spinal; Anesthesia, General

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: September 20, 2023
• Primary Completion: January 30, 2024
• Study Completion: February 15, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)